Merck & Co., Inc., with U.S. headquarters in Kenilworth, NJ, and which is known as MSD outside the U.S. and Canada, plans to move its European clinical operations to central London, UK. Its current UK headquarters are in Hoddesdon, Hertfordshire. The new location will bring in 150 new scientists and 800 additional staff.

The move is in part related to Brexit, the UK’s exit from the European Union (EU). Europe’s version of the U.S. Food and Drug Administration (FDA), known as the European Medicines Agency (EMA), is leaving London because of Brexit in the next 18 months.

John Carroll, writing for Endpoints News,notes, “Kenilworth, NJ-based Merck is willing to invest about $1.3 billion in the new center, with plans to recruit 150 top scientists for the new hub operations. And City A.M. reports that Merck will relocate staff at a facility in Hoddesdon, Hertfordshire. The move is being timed to coordinate with the release of the government’s Industrial Strategy White Paper.”

The move is part of a deal the UK government made with the life sciences sector. The Industrial Strategy White Paper will be released today, along with the government’s announcement of four sector deals. The other sectors include construction, artificial intelligence and automotive industries.

The UK’s Business Secretary, Greg Clark, said in a statement, “We are an open, flexible economy, built on trade and engagement with the world. We have a competitive business environment with a deserved reputation for being a dependable and confident place to do business, thanks to our high standards, respected institutions and a reliable rule of law.”

The UK government is investing 725 million pounds ($970.27 million, U.S.) in an effort to “transform” Britain’s industries over the next three years, The Times reported. That is in addition to the 1 billion pounds that had already been announced. The funds include 210 million pounds focused toward diagnosing disease earlier, and 170 million pounds aimed at building energy-efficient affordable housing.

Louise Houson, managing director of Merck in the UK and Ireland, told City A.M., “We believe London to be a unique bioscience center of excellence and a key component of the established golden triangle for academic science of London-Oxford-Cambridge.”

The company expects to have the facility in London operational by 2020. Meanwhile, it expects to open a smaller, temporary research facility in the area and begin recruiting scientific personnel.

Carroll reports, “The Financial Times is also reporting that Qiagen is hatching plans to invest hundreds of millions more into a new genomics center in Manchester. And the FT adds that government officials are hinting at more such announcements in the near future as they seek to reassure the public in a strong post-Brexit life sciences sector.”

He goes on to say, “The UK’s big anchors in drug R&D remain in the hands of Emma Walmsley at GlaxoSmithKlineand AstraZeneca’s Pascal Soriot, who’s planning to wrap a massive new HQ and research center in Cambridge. The Golden Triangle of London, Oxford and Cambridge remains one of the world’s top biotech hubs.”

After two years of treatment, patients on PRX-102 showed improvement across all key Fabry disease parameters. The treatment also proved to be fairly safe and tolerable for patients, the company said.

“These long term results further support that PRX-102 has the potential to be a significant differentiated therapy when compared to currently approved enzyme replacement therapies, and carries an important hope for all Fabry patients,” trial investigator Raphael Schiffmann from the Institute of Metabolic Disease at Baylor Research Institute, said in a statement.

Despite that positive news on its pipeline, Protalix is reportedly set to terminate 50 employees, which amounts to about 20 percent of its workforce. Israel’s Calcalist said the company has already notified its employees of the job cuts. The layoffs are part of a streamlining process, according to the report. PRX-102 is the company’s chemically modified version of the recombinant protein alpha-Galactosidase-A protein. It is being investigated in several Phase III trials for treatment of Fabry disease.

Two years ago, Protalix shifted its focus to developing treatments for Fabry disease, a genetic disease characterized by a deficiency of the enzyme alpha-galactosidase A. The lack of the enzyme causes a buildup of fatty molecules that prevent cells in the gastrointestinal system, kidney, heart, brain and nervous system from functioning properly.

“Following the implementation of Protalix’s strategic plan, the company has decided to focus most of its development efforts on its lead candidate for treating Fabry disease, and continue the development of its other pipeline drugs with partners,” a company spokesman told Calcalist in a statement.

In addition to the change in disease focus, Protalix said the layoffs were necessary due to the loss of some grant money provided to the company from the Israeli Innovation Authority. Grants dropped from $6 million in 2016 to $3.2 million in 2017, Calcalist said.

In October, Protalix and Italy-based Chiesi Farmaceutici SpA entered into a licensing and collaborative agreement for PRX-102. Protalix has licensed PRX-102 to Chiesi for all markets outside of the United States, under terms of the deal, which is worth up to about $400 million.

Earlier this month, Protalix reported that the deal with Chiesi significantly improved the company’s financial position. In its earnings report, Protalix said it has sufficient funding for operations through 2020. Moshe Manor, Protalix’s president and chief executive officer, said the deal with Chiesi allowed the company to “secure a strong, experienced clinical and commercial partner: as well as “meaningfully increase” the company’s capital resources.

CENTENNIAL, Colo., Nov. 27, 2017 /PRNewswire/ — Cochlear Limited (ASX: COH), the world leader in implantable hearing solutions, has received U.S. Food and Drug Administration approval for the first remote feature to allow follow-up programming sessions for the Nucleus® Cochlear Implant System through a telemedicine platform. This approval is the first in the cochlear implant industry and one of many steps Cochlear is taking to enable remote care for Nucleus Cochlear Implant recipients and clinicians.

“This approval will open the door for so many cochlear implant patients who have trouble accessing continued care because they can’t travel to an implant center,” said Allison Biever, Au.D., CCC-A, Director of Cochlear Implants at Rocky Mountain Ear Center, Englewood, Colo. “Cochlear implant technology is life transforming and the technology is maximized when coupled with adequate follow-up appointments so adjustments can be made to provide the best hearing performance for each patient. It is exciting that our industry and its patients will have access to remote care in the future.”

For most cochlear implant recipients, there are regularly scheduled follow-up appointments after the initial programming visit. These follow-up appointments help maximize the patient’s hearing and typically mean taking time off work or time out of school for the visit to the audiologist’s office. Leveraging telehealth within the cochlear implant industry provides clinics with more options to care for their patients no matter where their office is located, and it allows Nucleus Cochlear Implant recipients to receive care from the comfort of their own home. In addition, the expanded access to internet, smartphones and tablets coupled with Cochlear’s advanced wireless and Bluetooth® connectivity provide the technological foundation to open telehealth for its customers.

“We know clinicians are looking for options in providing care to their patients. We also know that for many cochlear implant recipients, follow-up programming means taking time out of their personal lives and many have to travel long distances,” said Tony Manna, President, Cochlear Americas. “As we continue to build our remote care offering and technology platforms, we can make access to care easier for both recipients and clinicians.”

Telehealth continues to grow as a successful service option in healthcare systems today, with many states, large hospital networks, and even the Centers for Medicare and Medicaid Services (CMS) working toward better access to care through remote options. Access to services and changes in healthcare along with the growing demand for cochlear implant services require a change in the care delivery model in order to expand access.

“Improved care delivery for those needing cochlear implant service should account for those who are medically fragile, geographically isolated, in need of transportation or impacted by weather-related issues,” said Mickey Brown, Vice President, Health Economics and Access, Cochlear Americas. “Through remote technology, we can help our cochlear implant recipients connect to their audiologist when they need care and where they want care. With this approval, clinicians interested in providing remote programming services can now approach healthcare providers in obtaining appropriate codes for reimbursement of these services.”

Early next year supplemental labelling, including instructions for use, will be added to Custom Sound®, the Cochlear fitting software, to guide clinicians in remote programming. This approval is an important building block for Cochlear’s future to build out a full-service telehealth platform for Nucleus Cochlear Implant recipients and clinicians.

About Cochlear Limited (ASX: COH)
Cochlear is the global leader in implantable hearing solutions. The company has a global workforce of more than 3,000 people and invests more than AUD$150 million a year in research and development. Products include hearing systems for cochlear implants, bone conduction and acoustic implants, which are designed to treat a range of moderate to profound types of hearing loss.

Over 450,000 people of all ages, across more than 100 countries, now hear because of Cochlear.www.cochlear.com/us

(Reuters) – Biogen Inc said on Monday it has licensed Alkermes Plc’s multiple sclerosis (MS) drug, further boosting its position in the race for the next treatment amid slowing sales of its own flagship MS drug, Tecfidera.

Biogen’s deal to buy the rights to develop and market Alkermes’ MS drug comes after the drugmaker in January licensed Danish company Forward Pharma A/S’s drug patents covering the same condition for $1.25 billion.

Biogen’s deal with Alkermes is a “defensive play” that could better position the Tecfidera franchise in the long term in an increasingly competitive space, and for a relatively modest cost, RBC Capital Markets analyst Brian Abrahams said.

He said he did not view Alkermes’ drug as a major competitive threat to Tecfidera, but it could have the potential to help Biogen retain some market share.

Biogen said it will reimburse Alkermes half of the expenses it incurred this year to develop the drug and will pay all expenses from next year for the drug, which is in late-stage studies.

Alkermes is also eligible to receive milestone-based payments of about $200 million, including an initial $50 million this year, as well as royalties on the drug’s sales.

Alkermes’ drug, ALKS 8700, is also being separately tested for its ability to irritate the gastrointestinal functions less than Tecfidera. Data from this study is expected in the first half of 2018.

Biogen’s shares were little changed in early trading on Monday, while Alkermes dipped 0.7 percent.

Teva Announces New Organization Structure and Leadership Changes

JERUSALEM–(BUSINESS WIRE)–Nov. 27, 2017– Teva Pharmaceutical Industries Ltd. (NYSE & TASE:TEVA) announced today a new organization and leadership structure aimed to achieve better commercial focus and drive value creation. The new structure will enable strategic alignment across the portfolio, across regions and between functions, leveraging scale, enhancing agility, extracting efficiencies and providing increased proximity to the markets. This new structure will be implemented effective immediately.

Kåre Schultz, Teva’s President and CEO, said, “Teva is taking decisive and immediate action to address external pressures and internal inefficiencies. Our new company structure will enable stronger alignment and integration between R&D, operations and the commercial regions, allowing us to become a more agile, lean and profitable company.”

Schultz continued, “We will focus on driving sustainable value creation. The new management team will position Teva for turnaround in the short to medium term. We are already working on a detailed restructuring plan for Teva and will share it in mid-December. It remains our absolute priority to stabilize the company’s operating profit and cash flow in order to improve our financial situation, while being focused on short-term revenue and cash generation, and at the same time, ensure we deliver on our commitment to supply high-quality medicines to patients around the world.”

New structure

The commercial business will no longer have two separate global groups for generics and specialty medicines, and will be integrated into one commercial organization, operating through three regions – North America, Europe and Growth Markets. Each of the regions will manage the entire portfolio – including generics, specialty and OTC – with full end-to-end P&L accountability. Some of the former global units will be integrated into the new structure, while others will be made redundant.

The former Generic R&D and Specialty R&D organizations will be combined into one global group with overall responsibility for all R&D activities – generic, specialty and biologics – maximizing ROI through better focus and efficiency.

A newly formed Marketing & Portfolio function will be responsible for overseeing the interface between regions, R&D and operations throughout all product lifecycle stages and optimizing generic and specialty portfolios across the therapeutic areas.

The new structure will enhance alignment and seamless integration between Teva’s Global Operations, the commercial regions, R&D and the Portfolio function, will increase productivity and simplify the organization.

The commercial structure will rely on one leaner supporting organizational infrastructure that includes Finance, Legal, HR, and Global Brand & Communications.

As a result of these changes, Dr. Michael Hayden, Dr. Rob Koremans and Dipankar Bhattacharjee will retire from Teva, effective December 31, 2017.

New executive management team

Michael (Mike) McClellan is appointed Executive Vice President, Chief Financial Officer and will oversee the Finance Group, Business Development, Investor Relations and Information Technology.Previously, he served as Interim CFOandas SVP & CFO Global Specialty Medicines. Prior to joining Teva, Mike was the U.S. CFO at Sanofi.

Dr. Hafrun Fridriksdottir is appointed Executive Vice President, Global R&D. Previously, she served as President of Global Generics R&D. Prior to joining Teva, Hafrun served as Senior Vice President and President of Global Generics R&D in Allergan plc.

Brendan O’Grady is appointed Executive Vice President, North America Commercial.Brendan has previously served as Chief Commercial Officer, Global Specialty Medicine, as interim head of Teva’s European specialty business and as President and CEO for Teva’s North America generics business and as VP US Market Access and Reimbursement.

Richard Daniell is appointed Executive Vice President, European Commercial, after having served as President and CEO, Teva Generics Europe.

Gianfranco Nazzi is appointed Executive Vice President,Growth Markets Commercial. Gianfranco has previously served as President and CEO of Growth Markets at the Global Generic Medicines group, and prior to that he was he has served as Senior Vice President, Specialty Medicines Europe.

Sven Dethlefs is appointed Executive Vice President, Global Marketing & Portfolio. He previously served as Global Head of Respiratory Medicines and as Chief Operating Officer, Teva Global Operations.

All appointments are effective immediately, while the retiring executives will stay with Teva to support the transition until the end of the year.

The following members of Teva’s executive management team will continue in their current positions:

Kåre Schultz concluded, “I would like to thank Dr. Michael Hayden, Dr. Rob Koremans and Dipankar Bhattacharjee for their profound contributions to Teva over the past decade and for their tireless dedication to the many patients we serve.”

Bios of new appointments

Michael (Mike) McClellan has been serving as Teva Interim Group CFO since July 2017. Prior to this role, he had served as SVP & CFO Global Specialty Medicines since July 2015. Prior to joining Teva, Mike was the U.S. CFO at Sanofi, where his career spanned nearly 20 years in roles of increased responsibility in global finance and healthcare. Mr. McClellan received his BSBA, Accounting & Economics from the University of Missouri Trulaske College of Business.

Dr. Hafrun Fridriksdottir has been serving as Executive Vice President, President of Global Generics R&D since February 2017, after serving as Senior Vice President and President of Global Generics R&D from 2016. Prior to joining Teva, from 2015 to 2016, Ms. Fridriksdottir served as Senior Vice President and President of Global Generics R&D in Allergan plc. From 2002 to 2015, she held positions of increasing responsibility within the Actavis Group, including Senior Vice President, R&D. From 1997 to 2002, Ms. Fridriksdottir served as Divisional Manager of Development at Omega Pharma, until its merger with Actavis. Ms. Fridriksdottir started her career as a scientist for 2 years at a research and development company owned by Pharmacia in Sweden, after receiving an MS degree in pharmacy and a Ph.D. in physical pharmacy from the University of Iceland.

Brendan O’Grady has been serving as Chief Commercial Officer, Global Specialty Medicine division since Aug 2016. In addition, he currently serves as the interim head of Teva’s European Specialty business. Prior to these roles, Mr. O’Grady held the position of President and CEO for Teva’s North America generic business in 2015 and held various senior roles since he joined Teva in 2011 as Regional Account Manager. Prior to joining Teva, Mr. O’Grady spent 10 years with Sanofi predecessor companies in a variety of commercial and medical affairs roles that began in field sales. He received his B.S. from Geneseo State University, NY in Management Science/Marketing and holds an M.B.A. from Baker University in Baldwinsville, Kansas.

Gianfranco Nazzi has been serving as President & CEO of Growth Markets, Global Generic Medicines Group since March 2017. Mr. Nazzi joined Teva as Senior Vice President Specialty Medicines Europe in 2014. Prior to joining Teva, he served 7 years at AstraZeneca in various senior roles, including Sales and Marketing Vice President Europe, Global Vice President Respiratory, General Manager of the Balkans and Vice President Primary Care in Italy. At GlaxoSmithKline he served for two years as BU Director Metabolic & Cardiovascular and at Eli Lilly and Company he served for 5 years in various sales and marketing roles in both Italy and the US. He began his career at Danieli. Mr. Nazzi received his BA degree in economics from the University of Udine, and his Masters degree in Management Studies from SDA Bocconi.

Richard Daniell has been serving as President and Chief Executive Officer, Teva Generics Europe since Dec 2016. Prior to that, he had served as Chief Integration Officer Leading Actavis-Teva Integration since Sep 2015 after holding various senior roles, including Chief Operating Officer, Growth Markets and Regional General Manager for Teva in the UK and Ireland from 2012 through 2014. Mr. Daniell joined Teva as Senior Director Teva UK Limited in 2006, following the acquisition of IVAX Pharmaceuticals UK. Prior to joining Teva, he served three years at IVAX Pharmaceuticals UK as Director of Generics. Mr. Daniell received his BSc in chemistry from the University of Auckland.

Sven Dethlefs has been serving as Global Head of Respiratory Medicines, Global Specialty Medicines since January 2016. Prior to that, he had served as Chief Operating Officer, Teva Global Operations, since October 2013. Mr. Dethlefs joined Teva as General Manager, Teva Germany in 2008. Prior to joining Teva, he served for over 11 years as a partner at McKinsey & Company. Mr. Dethlefs received his PhD in biochemistry from the FU Berlin/Pasteur Institute Paris.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in over 60 markets every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva’s net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

uncertainties relating to the potential benefits and success of our new structure and recent senior management changes as well as the potential success and our ability to effectively execute a restructuring plan;

our generics medicines business, including: that we are substantially more dependent on this business, with its significant attendant risks, following our acquisition of Allergan plc’s worldwide generic pharmaceuticals business (“Actavis Generics”); our ability to realize the anticipated benefits of the acquisition (and any delay in realizing those benefits) or difficulties in integrating Actavis Generics; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; price erosion relating to our generic products, both from competing products and as a result of increased governmental pricing pressures; and our ability to take advantage of high-value biosimilar opportunities;

our substantially increased indebtedness and significantly decreased cash on hand, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, and may result in a downgrade of our credit ratings;

our business and operations in general, including: our ability to develop and commercialize additional pharmaceutical products; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel;the restructuring of our manufacturing network, including potential related labor unrest; the impact of continuing consolidation of our distributors and customers; variations in patent laws that may adversely affect our ability to manufacture our products; our ability to consummate dispositions on terms acceptable to us; adverse effects of political or economic instability, major hostilities or terrorism on our significant worldwide operations; and our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions;

compliance, regulatory and litigation matters, including: costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; governmental investigations into sales and marketing practices; potential liability for sales of generic products prior to a final resolution of outstanding patent litigation; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;

other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; the significant increase in our intangible assets, which may result in additional substantial impairment charges; potentially significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;

and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise.You are cautioned not to put undue reliance on these forward-looking statements.

(Reuters) – Regeneron Pharmaceuticals is dropping plans to develop a new eye drug combination, marking a setback for the U.S. biotech company as Swiss rival Novartis seeks to snatch sales from its existing Eylea medicine.

Results from two mid-stage clinical trials that added nesvacumab to Eylea “did not provide sufficient differentiation to warrant Phase 3 development”, Regeneron said on Monday.

“We knew from the start that it would be difficult to improve on the already high bar set by Eylea,” said president and chief scientific officer, George Yancopoulos.

Eylea, on which Regeneron has partnered with Bayer, generates annual sales of $5 billion but faces looming competition from an experimental Novartis drug known as RTH258, which has shown advantages over Eylea in clinical trials run by the Swiss group.

Both drugs are designed primarily to treat wet, age-related macular degeneration, where abnormal, leaky blood vessels can cause blindness. The condition affects 20-25 million people worldwide.

Bayer pharmaceuticals head says there’s no pipeline problem

By Ludwig Burger and Patricia Weiss | LEVERKUSEN, GERMANY

Bayer is seeking to defend its pharmaceuticals business that will be diluted in importance by the takeover of Monsanto and faces a threat to revenues in 2024 when the blockbuster heart drug Xarelto loses its patent.

The firm’s planned takeover of U.S. seeds group Monsanto for $63.5 billion has prompted concerns among some of the German group’s shareholders, who say the drugs unit may not get the funding needed to deliver an adequate drugs pipeline.

The healthcare unit, covering pharmaceuticals and consumer health, now accounts for about two-thirds of Bayer’s sales. In the combined group, its revenues will be roughly on par with those of seeds and pesticides.

Bayer’s head of pharmaceuticals, fresh from a cancer drug deal worth up to $1.55 billion last week, said Bayer’s drugs pipeline would keep the unit buoyant and could cope with losing Xarelto’s patent protection in 2024.

“We have increased our R&D spend by more than a billion euros since I arrived and we have now more than 50 projects in clinical development. We don’t have a pipeline problem,” said Bayer’s pharmaceuticals head, Dieter Weinand, who joined in 2014 after roles at Pfizer and Bristol-Myers Squibb.

“Buying additional pipeline would require additional funding for an even larger pipeline, which I don’t actually need at the moment,” he told Reuters, adding Bayer could seek smaller bolt-on takeovers or licensing deals.

Fund managers such as Jupiter Asset Management and Union Investment said last year Bayer risked neglecting its pharmaceuticals business by pursuing Monsanto.

Two fund managers, who hold Bayer shares but asked not to be named, said on Wednesday the Xarelto patent expiration was a challenge.

“I would like to see more moves to strengthen the pipeline, but the question is, will they be able to finance them?” said one, saying there was “a danger that the pharma unit will be underinvested”.

Weinand said Bayer had proved it could maintain revenues, citing the firm’s track record in seeing late-stage drugs to market maturity, such as Xarelto, which generates almost 20 percent of sales for Bayer’s prescription drugs unit.

Bayer said last year its six most promising drugs under development would have combined peak annual sales of at least 6 billion euros, a figure analysts called optimistic.

But progress has been mixed. Lymphoma drug copanlisip has won U.S. approval but anetumab ravtansine, a drug for asbestos-linked cancer type mesothelioma, failed the Phase II trial.

Weinand said there was still hope in the anetumab results as about a third of trial participants showed durable tumor shrinkage, and said Bayer aimed to find diagnostic tools to predict which patients were hopeful candidates before treatment.

The recent Compass trial showed Xarelto could treat people with severe atherosclerosis, potentially adding revenues now but leaving an even steeper drop when the patent ends.

Analysts on average see annual peak sales of between $5.5 billion and more than $6 billion before Xarelto goes off patent.

Weinand said Bayer was being “prudent” with a projection of more than 5 billion euros in sales in Xarelto’s best year, up from 2.9 billion euros in 2016.

“What has changed that outlook is the really unique data on Compass that increased the revenue base at time of loss of exclusivity. Now the gap has increased, but that’s a great problem to have,” he said.

The Boston Business Journal first reported that the company, focused on developing small molecule therapies for cancer and other disease, has quietly closed up shop after 13 years. During that time, Ensemble Therapeutics struck a number of deals with large pharma companies, but was unable to secure enough financing to stay afloat, the Journal said. (The Journal’s article requires a paid subscription.) In 2016, XConomy reported that Ensemble had raised about $43.5 million in total equity financing since it launched in 2004. That seems a significantly small amount for a biotech over the course of more than a decade. It also seems that the company was unable to generate any significant return for its investors.

Ensemble Therapeutics’ website is still online and there is no information posted about shuttering its doors. Calls to the Massachusetts-based company results in a recorded message that says the telephone number is no longer a working number.

The company has not issued a press release since May of 2016. That press release centered on a deal with Swiss pharma giant Novartis, which acquired the rights to expand its access to Ensemble’s interleukin-17 (IL-17) antagonist program. That deal was an expansion of a collaborative agreement first established in 2013.

In March 2013, the company announced it achieved an early-stage research milestone in its drug discovery collaboration with Alexion Pharmaceuticals Inc. Connecticut-based Alexion was applying Ensemble’s drug discovery platform against several therapeutic targets to discover new small molecule clinical candidates. Whatever the milestone was that Ensemble achieved was never specified.

Ensemble Therapeutics was founded in 2004 by Harvard Professor David R. Liu. The company’s focus was on developing synthetic macrocycle drugs. Macrocycles, the company said on its site, are “uniquely suited to address many protein targets that cannot be modulated effectively by traditional small molecule pharmaceutical compounds.” Ensemble’s lead oncology program was focused on the immune checkpoint target Indoleamine 2,3-dioxygenase 1 (IDO).

Ensemble was launched by noted venture capital group Flagship Ventures. It was also backed by Arch Venture Partners, Presidio Partners and Boston University.

During its 13-year run, the company had not been able to see any of the drug candidates in its in-house pipeline enter the clinic. On its website, Ensemble noted at least three of its own therapies were in preclinical phases and the rest were in the discovery phase.

]]>FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patientshttp://www.pharmalive.com/fda-approves-first-implanted-lens-that-can-be-adjusted-after-cataract-surgery-to-improve-vision-without-eyeglasses-in-some-patients/
Wed, 22 Nov 2017 17:14:30 +0000http://www.pharmalive.com/?p=137601

SILVER SPRING, Md., Nov. 22, 2017 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses.

Cataracts are a common eye condition where the natural lens becomes clouded, impairing a patient’s vision. Following cataract surgery, during which the natural lens of the eye that has become cloudy is removed and replaced with an artificial lens (intraocular lens, or IOL), many patients have some minor residual refractive error requiring use of glasses or contact lenses. Refractive error, which is caused when the artificial lens does not focus properly, causes blurred vision.

“Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat at the FDA’s Center for Devices and Radiological Health. “This system provides a new option for certain patients that allows the physician to make small adjustments to the implanted lens during several in-office procedures after the initial surgery to improve visual acuity without glasses.”

The RxSight IOL is made of a unique material that reacts to UV light, which is delivered by the Light Delivery Device, 17-21 days after surgery. Patients receive three or four light treatments over a period of 1-2 weeks, each lasting about 40-150 seconds, depending upon the amount of adjustment needed. The patient must wear special eyeglasses for UV protection from the time of the cataract surgery to the end of the light treatments to protect the new lens from UV light in the environment.

A clinical study of 600 patients was conducted to evaluate the safety and effectiveness of the RxSight Light Adjustable Lens and Light Delivery Device. Six months after the procedure, patients on average saw an improvement of about one additional line down the vision chart, for distance vision without glasses, compared to a conventional IOL. Six months after surgery, 75 percent also had a reduction in astigmatism.

The device is intended for patients who have astigmatism (in the cornea) before surgery and who do not have macular diseases.

The device should not be used in patients taking systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypercin, ketoprofen, piroxicam, lomefloxacin and methoxsalen. Treatment in patients taking such medications may lead to irreversible eye damage. The device is also contraindicated in cases where patients have a history of ocular herpes simplex virus.

The FDA approved the Vision Light Adjustable Lens and the Light Delivery Device to RxSight Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

On Friday, November 17, Genentech, a Rochecompany, suedPfizer in a federal court in Wilmington, Delaware, over Pfizer’s biosimilar for Genentech’s Herceptin. Genentech is claiming that Pfizer’s proposed biosimilar infringes 40 of its patents. Genentech also is demanding compensation for lost sales if Pfizer launches its copycat version before the Herceptin patents expire.

In 2016, Herceptin brought in $2.5 billion in U.S. sales. The drug was approved by the U.S. Food and Drug Administration (FDA) in 1998 and is used to treat breast cancer. Pfizer’s biosimilar is PF-05280014. A biosimilar is essentially a generic version of a biologics drug.

BloombergTechnology writes, “Roche is leaning on new drugs such as the multiple sclerosis therapy Ocrevus to drive growth as its three most lucrative drugs—the cancer-fighting trio of Herceptin, Rituxan and Avastin—face competition from biosimilars or newer treatments. The company could lose almost $4 billion in sales to the cheaper versions of the three drugs in 2020, Sanford C. Bernstein & Co. said in April. Roche has said that competition for its two best-selling medicines, Rituxan and Herceptin, will probably start to have an impact on revenue in 2018.”

Genentech’s concerns are legitimate. On Sunday, Nov. 20, the European Commission approved Samsung Bioepis Co. Ld‘s Ontruzant, a biosimilar of Herceptin. Europe is ahead of the U.S. in the biosimilar market. It’s been seven years since Congress passed laws allowing biosimilars, but so far the FDA has only approved five, while 25 have been approved in Europe. The rationale, much like that for generics, is that the competition will push down drug prices.

BloombergTechnology notes, “Regulatory approval isn’t the only hurdle for copies of biotechnology drugs like Herceptin. The drugs are complex, and it’s not unheard of for one to be tied to more than 100 patents, which can generate extensive litigation. And drugmakers may use contracts with drug plans and insurers to thwart competitors.”

This isn’t the first time Pfizer has gotten tangled in lawsuits over biosimilars. Its first biosimilar, Inflectra, launched in the U.S. in October 2016. Inflectra is a biosimilar to Johnson & Johnson’s Remicade. Pfizer proactively sued J&J, arguing that it was engaged in anti-competitive practices intended to block Inflectra.

The Center for Biosimilars notes, “While Pfizer has not yet announced its submission of a Biologics License Application for its proposed trastuzumab biosimilar, it has released positive data from a comparative clinical trial comparing PF-05280014 to reference trastuzumab in patients with operable HER2-positive early breast cancer. The study demonstrated that PF-05280014 had similar safety, efficacy, and immunogenicity to its reference, and that it was non-inferior, in terms of pharmacokinetics, to the reference drug.”

And it’s not Pfizer’s only biosimilar in the pipeline. It also has biosimilar in Phase III development for Humira (adalimumab), Avastin (bevacizumab), Epogen and Procrit (epoetin alfa), Rituxan and MabThera (rituximab). The Center for Biosimilars says, “Forbes reports that the total sales of the reference products targeted by Pfizer totaled over $35 billion in 2014, and that ‘Theoretically speaking, replacing [these drugs’] entire sales with biosimilars even with a 50 percent pricing discount will open up a market worth nearly $18 million for Pfizer.’”